Optimizing Medical Device

Development with Quality in Mind

John Daley

Multi-Site Vice-President, Quality

Boston ScientificSeptember 2015

1

Disclaimer

• The opinions, strategies and examples

presented here are my own and do not

necessarily reflect those of my current or

former employers.

2

This Talk

• We have 35 minutes.

• I hope to talk for about 20 and have all of us

talking for 15.

• In 20 minutes, I can’t go into great detail so we

will hit the highlights and go where the room

wants to go.

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About Me – The Good

• BSME, University of Rhode Island

• MBA, SUNY-Albany

• Started out in the design world (Non-

FDA)

• Entered Devices (Davol/Bard) in 1992

4

Crucible (cru·ci·ble - kro͞osəb(ə)l/)

noun

• a ceramic or metal container in which

metals or other substances may be

melted or subjected to very high

temperatures.

• a place or occasion of severe test or

trial.

– "the crucible of combat"

• a place or situation in which different

elements interact to produce

something new.

– "the crucible of the new Romantic

movement"

5

About Me – My Crucibles

• LifeScan – Probation

Agreement ($59MM

Fine)

• Cordis – FDA Corporate

Warning Letter on April 1,

2004

• Boston Scientific – FDA

Corporate Warning

Letter on January 25,

2006

• They were raided in April

of 1998. I started in Feb.,

1999

• I started in October, 2004

• I started in March, 2007

6

“The Room”

• Who has been part of a:

– Warning Letter

– Consent Decree

– Corporate Warning Letter

• Who works in:

– Capital Equipment

– Disposables

– Reusables

– Software7

My Big Fat, Greek Wedding

• Gus Portokalos: Give me a word, any word, and

I show you that the root of that word is Greek.

• Gus Portokalos: Kimono, kimono, kimono. Ha!

Of course! Kimono is come from the Greek word

himona, is mean winter. So, what do you wear in

the wintertime to stay warm? A robe. You see:

robe, kimono. There you go!

8

What is “Design Control”

• I like Wikipedia’s definition: “. . . a formal

methodology to the conduct of product

development activities”

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Source:

https://en.wikipedia.org/wiki/Design_controls

Some FDA Guidance*

• This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001

• March 11, 1997

• FOREWORD

• To ensure that good quality assurance practices are used for the design of medical

devices and that they are consistent with quality system requirements worldwide,

[SNIP]

• Because design controls must apply to a wide variety of devices, the regulation does

not prescribe the practices that must be used. Instead, it establishes a framework

that manufacturers must use when developing and implementing design controls.

The framework provides manufacturers with the flexibility needed to develop design

controls that both comply with the regulation and are most appropriate for their own

design and development processes.

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*Emphasis added

Source: http://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm

The Framework

• SECTION B. DESIGN AND DEVELOPMENT PLANNING 9

• SECTION C. DESIGN INPUT 13

• SECTION D. DESIGN OUTPUT 21

• SECTION E. DESIGN REVIEW 25

• SECTION F. DESIGN VERIFICATION 31

• SECTION G. DESIGN VALIDATION 35

• SECTION H. DESIGN TRANSFER 39

• SECTION I. DESIGN CHANGES 41

• SECTION J. DESIGN HISTORY FILE (DHF) 45

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John’s Big Fat Design System

• Give me a project failure, any project

failure, and I’ll trace it back to a failure to

meet a . . .

REQUIREMENT

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At The Risk of Oversimplifying

• Requirements

• Design

• Build

• Test

• Maintain

13

Three Keys To Success

• Culture

• Systems

• People

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Bad Culture

• Two harbingers of DOOM:

“Why can’t we let the paperwork catch up

with the product?”

“Can’t we sign a temporary deviation?”

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Good Culture

• We follow our procedures and processes

• When we can’t do that – we raise our

hands and change the process!

– Using the appropriate processes, of course

• We balance the needs of all stakeholders

16

Systems

• Are scaled to your needs

– Paper-based → Spreadsheet-Based → PLM-

Based

• You have a REAL requirements

management system

– As “real” as your size allows

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People

• Know their jobs and have clarity on what their

responsibilities are.

– GANNT chart or equivalent is a MUST

• Are competent

• Are deadline-driven but not deadline-obsessed

– You can’t just focus on being green on the

scorecard

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Shared Best Practices

• Heavy emphasis on requirements

gathering and management.

• Separates Idea development from Product

development

– Many projects need to spend time developing

the idea so that the challenges are

understood and the timelines can be

realistically developed.

19

Best Practices (II)

• Project Managers are not the developers

and have some independence.

• Uses “Core” and “Extended” teams.

• Timelines are never fully reset – let me

explain . . .

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Summing It Up

• You are only as good as your requirements.

• Your system determines your product.

• “I can explain that” is a last resort.

• The more heroics you need, the worse shape

you are in.

• Have Fun (what? How the heck can I even say

that?)21

Thanks For Listening

• Questions?

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